美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA011265"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
62559-758-04 62559-758 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide SOLUTION ORAL 20240905 N/A NDA AUTHORIZED GENERIC NDA011265 ANI Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 118 mL in 1 BOTTLE (62559-758-04)
62559-758-16 62559-758 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide SOLUTION ORAL 20240905 N/A NDA AUTHORIZED GENERIC NDA011265 ANI Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 473 mL in 1 BOTTLE (62559-758-16)
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